Cleared Traditional

E1000 Dx Digital Pathology Solution

K241717 · Shandon Diagnostics Limited · Pathology

Feb 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K241717 is an FDA 510(k) clearance for the E1000 Dx Digital Pathology Solution, a Whole Slide Imaging System (Class II — Special Controls, product code PSY), submitted by Shandon Diagnostics Limited (Runcorn, GB). The FDA issued a Cleared decision on February 28, 2025, 259 days after receiving the submission on June 14, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number	K241717 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2024
Decision Date	February 28, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PSY — Whole Slide Imaging System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.3700
Definition	The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).